Healthy ParticipantPhase 1NCT07130097
A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants
A Phase 1 study testing PF-07220060 in people with Healthy Participant, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant
- What is being tested?
- PF-07220060
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 18 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A positive urine drug test
- Unwilling or unable to comply with the Lifestyle Considerations criteria of this study
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, 06511
About this study
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE ATIRMOCICLIB (PF-07220060) HIGHER DRUG LOAD IR MST TABLETS AND ATIRMOCICLIB IR MST TABLETS ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market.
The study is seeking participants who are:
Read more
- Healthy males and females aged 18 to 65 years
- Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
- Body Mass Index of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (kg) [110 pounds (lb)].
Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin).
The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.
- Conditions
- Healthy Participant
- Being tested
- PF-07220060
- Keywords
- Healthy Participants, ,, Bioequivalence, Bioavailability, Pharmacokinetics, Tablet Formulation, Crossover Study, ADME (Absorption, Distribution, Metabolism, Elimination)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07220060Drug
Also called Atirmociclib
Cyclin-dependent kinase-4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Regimen A; Treatment Sequence A | Experimental | Single Oral Dose of reference tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of test tablet formulation PF-07220060 Receives: Drug: PF-07220060 |
| Regimen B; Treatment Sequence B | Experimental | Single Oral Dose of test tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of reference tablet formulation PF-07220060 Receives: Drug: PF-07220060 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf)
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (If data does not permit reporting of AUCinf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Measured: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
Area under the Plasma Concentration-Time profile (AUC) from time 0 extrapolated to extrapolated infinite time (AUCinf) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data permits).
AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits). It is obtained from AUC (0-t) plus AUC (t-inf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Measured: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
Maximum Observed Plasma Concentration (Cmax) profile of test and reference atirmociclib formulations after a high fat/high calorie meal
Cmax was the maximum observed plasma concentration directly observed from data. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Measured: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
Secondary outcomes (4)
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Measured: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Measured: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Measured: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start14 Aug 2025
- Primary completion26 Oct 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130097
- Sponsor's protocol ID
- C4391009
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE ATIRMOCICLIB (PF-07220060) HIGHER DRUG LOAD IR MST TABLETS AND ATIRMOCICLIB IR MST TABLETS ADMINISTERED UNDER FED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
- ClinicalTrials.gov ID
- NCT07130097
- Acronym / sponsor ID
- C4391009
- Conditions
- Healthy Participant
- Keywords
- Healthy Participants, ,, Bioequivalence, Bioavailability, Pharmacokinetics, Tablet Formulation, Crossover Study, ADME (Absorption, Distribution, Metabolism, Elimination)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 26 Oct 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed higher drug load tablet that is already available in the market.
The study is seeking participants who are:
- Healthy males and females aged 18 to 65 years
- Willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures.
- Body Mass Index of 17.5-30.5 kilogram per meter squared (kg/m2); and a total body weight of more than 50 kilograms (kg) [110 pounds (lb)].
Participants in the study will receive a single dose of PF-07220060 by mouth after a meal, following at least 7 days, the participant will then receive another dose of PF-07220060. Each dose received by the participant will be a different tablet formulation, and the sequence of tablet formulations given will be random (just like a flipside of the coin).
The study will help the team understand how the difference in tablet formulation may, or may not, affect how the medicine is absorbed, processed, and removed by the body.
Participants will remain in the study clinic for at least 13 days and will have one follow-up contact.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen A; Treatment Sequence A | Experimental | Drug: PF-07220060Single Oral Dose of reference tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of test tablet formulation PF-07220060 |
| Regimen B; Treatment Sequence B | Experimental | Drug: PF-07220060Single Oral Dose of test tablet formulation PF-07220060, then at least 7 day washout, followed by a single oral dose of reference tablet formulation PF-07220060 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
- BMI of 17.5-30.5 kg/m2; and a total body weight >50 kg (110 lb).
- Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (4 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A positive urine drug test
- Unwilling or unable to comply with the Lifestyle Considerations criteria of this study
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-07220060Also: AtirmociclibCyclin-dependent kinase-4 inhibitor | Drug | Regimen A; Treatment Sequence A, Regimen B; Treatment Sequence B |
Primary outcome
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf)
Time frame: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (If data does not permit reporting of AUCinf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Area under the Plasma Concentration-Time profile (AUC) from time 0 extrapolated to extrapolated infinite time (AUCinf) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data permits).
Time frame: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits). It is obtained from AUC (0-t) plus AUC (t-inf). The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
Maximum Observed Plasma Concentration (Cmax) profile of test and reference atirmociclib formulations after a high fat/high calorie meal
Time frame: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data. The geometric coefficient of variation is expressed in percentage. The ratio (Test/Reference) of adjusted means and 90% CI are then expressed as percentages.
4 secondary outcomes
Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
Time frame: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
Time frame: From baseline up to 36 days after the last dose of study intervention (up to Day 36 post dose in period 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07220060 in people with Healthy Participant, run by Pfizer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Plasma Concentration-Time profile from time 0 to time of last quantifiable data point (AUClast)) of test and reference atirmociclib formulations after a high fat/high calorie meal (If data does not permit AUCinf) (time frame: Pre-dose, 0, 0.5, 0.75, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 16, 24, 36, 48, 72, 96, 120 hours post dose in period 1 and period 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.